Senior Design Quality Engineer: Lifecycle & Transfer Lead

AbbVie; North Chicago (IL); On-site; USD 110,000 - 155,000; Full time

Job summary

AbbVie is seeking a Sr. QE for Design Quality – Lifecycle Management to lead QA activities across cross-functional teams as products move from development to manufacturing and on-market.

You will drive design transfer, risk management, and change control, supporting regulatory submissions and audits with a strong quality mindset. Ideal candidates have a Bachelor's in Biology/Chemistry/Engineering and 6+ years in manufacturing, quality, or engineering, with excellent communication, problem

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering
• 6+ years of experience in Manufacturing, Quality or Engineering
• Good verbal and written communication skills
• Good problem solving and analytical skills
• Good interpersonal relations / communications skills
• Good negotiation skills
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing.

Responsibilities

• Perform QA activities related to Combination Product and Medical Device Design Transfer and Change Management
• Ensure compliance with company policies and procedures
• Perform design control and risk management activities according to AbbVie's Quality System
• Maintain DHF documentation
• Partner within Quality and Operations to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
• Perform 3rd party supplier management activities such as review 3rd party design control activities
• Support the creation of regulatory submission documentation
• Serve as the primary quality lead for design transfer activities to enable product launch, including transfers both within and outside of AbbVie
• Support equipment qualifications (IQ/OQ/PQ) and process validations
• Own change plans to manage on-market design changes, collaborate with cross-functional team for impact assessments, define and execute action plans, and monitor them to ensure timely closure
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure
• Initiate assignments independently. Actively lead and participate on development and process improvement teams. Anticipate/resolve quality issues and take preventative actions.
• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements. Write/review policies/processes/procedures and related documents
• Apply knowledge of global regulations, guidance's, and Corporate and Function standards
• Lead/assist in the preparation of and support regulatory agency and internal audits
• Conduct, lead, or participate in investigations and review boards for CAPAs, NCRs, Observations, etc.
• Participate in departmental Change Control activities, utilizing Design Control knowledge to perform design change impact assessments
• Review and approve changes relevant to the department
• Support interactions with regulatory authorities (e.g., Notified Body audits)
• Write and revise procedures, forms, and other documents, as needed
• Work with the cross-functional team to drive change and continuous improvement

Job description

AbbVie is seeking a Sr. QE for Design Quality – Lifecycle Management to lead QA activities across cross-functional teams as products move from development to manufacturing and on-market.

You will drive design transfer, risk management, and change control, supporting regulatory submissions and audits with a strong quality mindset. Ideal candidates have a Bachelor's in Biology/Chemistry/Engineering and 6+ years in manufacturing, quality, or engineering, with excellent communication, problem